To Big Pharma: Give us the data and we’ll give you the unvarnished truth

“I want to know with a good degree of certainty that a medication I recommend will do more good than harm. To our politicians I would ask you to give us the data and we will give you the real unvarnished truth. It will probably save you money and get you re-elected, unless of course you, too, take campaign funding from Big Pharma,” says scientist, Dr. James Freeman.

Controversy in medicine is nothing new. Science is like that. Scientists make observations, for example “High cholesterol is associated with greater rates of heart disease” and “Statin drugs lower cholesterol”. What happens next is joining the dots and asking a question, called a hypothesis. In the case of statins that hypothesis was “well, if statins lower cholesterol, and high cholesterol is associated with heart disease, would giving statins reduce heart disease?”

While that seems pretty reasonable as an idea, and an important question to ask, a scientist wants to see data proving that giving statins to real patients not only lowers their cholesterol but ALSO delivers the expected benefits. That’s sensible. Very few of us want lower numbers on lab reports. We want a longer healthier life. If statins don’t deliver that why bother? For some patients statins do deliver — they are not evil drugs and clearly have a place, but…

It’s worth remembering that there is no such thing as a 100 per cent safe drug. For every drug there are benefits and there are risks. The balance point comes no later than where the risks outweigh the benefits, however, I would argue that the balance point should really come well before the risks outweigh the benefits. Is it really worth it to take a medication every day for years where the net benefit is a few weeks extra life? Money we spend here is money we don’t have to spend there.

There is little doubt that statins do indeed produce real and measurable benefits in some patients. There is also little doubt that we should not put statins in the water supply and give them to every man woman and child. Between the two extremes of “give everyone statins” and “give nobody statins” there is a balance point. The question clearly posed by Dr Maryanne Demasi is “Have we gone too far?” I tend to think we may well have, but I, like everyone else can’t be sure because we can’t assess the data properly.

Without access to the raw data, there is not a single independent researcher who can assess where the balance point for statins actually is. We, as in we the people, or to be more specific, we the taxpayers and we the insurance payers, are the ultimate source of drug company funding. Drug companies demand high prices for their wares and it is not unreasonable that we should demand high proof of their value, after all, drug companies do not offer the usual money back warranties seen for other consumer goods.

We genuinely have the power to demand transparency because our politicians and payers control the purse strings. We should make that demand using this explicit lever. Show us the data, all of the data, or we will not subsidise your products. Not just for statins but for every drug we use. There exists the potential to make massive savings here and reduce the strain on our health systems. Do our politicians have the integrity to ask for data we have paid for many times over? I think they should, after all it is our money they are spending.

For years there have been calls that all clinical trial data should, by law, have to be published within one year of completion. The infrastructure for that publication already exists on sites like clinicaltrials.gov and yet the majority of trials registered here never report their results. This is simply not good enough. We have a right to expect better and the capacity to demand better.

In the USA, the media spend by Big Pharma on advertising is $5 billion a year — on doctors it is $3.5 billion a year, and on politicians it is $350 million a year. Call me a cynic but I think that’s a big part of the problem and I sincerely doubt commercial entities would spend so much money without a validated return on investment.

I am a scientist. I want to know with a good degree of certainty that a medication I recommend will do more good than harm. To our politicians I would ask you to take your lead from Richard Branson’s book and say “Screw it let’s do it.” Give us the data and we will give you the real unvarnished truth. It will probably save you money and get you re-elected, unless of course you too take campaign funding from Big Pharma.

We have the power. The real questions are do we have the will power, and do we have the integrity? I’d like to think we do, but sadly the evidence suggests we don’t.

Statins are undoubtedly useful for some patients, however, their utility for others has not really been adequately demonstrated and there are clear financial incentives to overprescribe them. We the people paid for the studies in the high prices levied by drug companies and I think we have a right to see that data. As a doctor, I don’t have the data to do my job. Jerry MacGuire and said “Show me the money!” I say the medical profession as a whole should rally and start shouting “Show me the data!”

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Dr James Freeman

James Freeman is the founding owner of GP2U Telehealth and an executive director with responsibilities for platform development and clinical oversight. He brings 20 years of clinical and information technology experience to the company and remains a Lecturer in Medicine at the University of Tasmania.

James has a B.Sc. and MB,BS from UTAS and is on the Dean’s Roll of Excellence for outstanding academic achievement.

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